Tag Archives: Latin America

INVIMA+ANMAT: inter-agency collaboration activities

Posted on February 28, 2014 by Maria I. Guaia

During the last Summit of Regulatory Authorities of Regional Reference that took place in Acapulco, Mexico, on the 10th to 21st of February, the representatives of Colombia’s INVIMA and Argentina’s ANMAT, Dr. Blanca Elvira Cajigas de Acosta and Dr. Carlos A. Chiale, … Continue reading →

Posted in Argentina, Colombia, Guatemala | Tagged ANMAT, Argentina, Colombia, Cooperation, Good Traceability Practices, Guatemala, INVIMA, Latin America, regulatory affairs | Leave a comment

Americas Health Authorities Meeting

Posted on February 24, 2014 by Maria I. Guaia

On the 20th and 21st of February of 2014, representatives of the five Latin-American Health Authorities of Regional Reference recognized by the Pan American Health Organization, plus those of the FDA, Health Canada, and El Salvador’s regulatory agency met in … Continue reading →

Posted in Argentina, Brazil, Canada, Colombia, Cuba, Mexico, Uncategorized, USA | Tagged ANMAT, anvisa, Argentina, brazil, Canada, CECMED, COFEPRIS, Colombia, Cooperation, Cuba, drug products, FDA, health authority, Health Canada, Latin America, Mexican Health Agency, Mexico, Mikel Arriola, National Regulatory Agency of Regional Reference, PAHO, Pan American Health Authorization, regulatory affairs | 2 Comments

Mexico at the vanguard with new combination drug

Posted on November 29, 2013 by Maria I. Guaia

In the past days, COFEPRIS granted approval for the combination drug containing fluticasone furoate and vilanterol, indicated for treatment of chronic obstructive pulmonary disease (COPD) and asthma. Although the product had already been approved in the US by the FDA in … Continue reading →

Posted in Mexico | Tagged Active Pharmaceutical Ingredients, Agreement for Innovation, API, COFEPRIS, drug products, EMA, EMEA, FDA, fluticasone, Latin America, Mexican Health Agency, Mexico, registration, regulatory affairs, vilanterol | 1 Comment

Argentina: Site Master File now required by ANMAT for national sites

Posted on November 27, 2013 by Maria I. Guaia

Starting on November 19th, 2o13, sites in Argentina approved by ANMAT to manufacture or package, in own or contract facility, or import or export, both drug products and APIs, have to submit their Site Master Files (SMF) annually. This is … Continue reading →

Posted in Argentina, Uncategorized | Tagged Active Pharmaceutical Ingredients, ANMAT, API, Argentina, drug products, electronic submission, GMP, Good Manufacturing Practices, inspections, Latin America, National Regulatory Agency of Regional Reference, new Disposition, regulatory affairs, Site Master File, SMF | 2 Comments

Brazil: ANVISA bans Lorcaserin (Belviq)

Posted on November 6, 2013 by Maria I. Guaia

Today ANVISA, the Brazilian health authority with competence on the control of pharmaceutical products and APIs, banned the manufacturing, import, commercialization, manipulation and use of the API Lorcaserin. Lorcaserin is the drug substance of Belviq, an innovative weight-loss product that … Continue reading →

Posted in Brazil | Tagged Active Pharmaceutical Ingredients, anvisa, Arena Pharmaceuticals, Belviq, brazil, drug adverse reactions, drug products, EMA, EMEA, FDA, Latin America, Lorcaserin, regulatory affairs | 3 Comments

Brazil: Overview of API registration

Posted on October 28, 2013 by Maria I. Guaia

In Brazil, the health authority (ANVISA) will require that all Active Pharmaceutical Ingredients (APIs) manufactured in Brazil, imported for manufacturing of drug products, or included in imported finished products, are registered with the agency. This regulation has been put in … Continue reading →

Posted in Brazil | Tagged Active Pharmaceutical Ingredients, anvisa, API, brazil, import, Latin America, manufacturing, registration | 8 Comments

Mexico: new guidelines for the acceptance of GMP certificates

Posted on October 18, 2013 by Maria I. Guaia

In October 2013, the Mexican health authority released a new document setting the criteria that will be used to accept GMP certificates as valid. This criteria applies to certificates of manufacturing facilities both of finished products and API. Summary of … Continue reading →

Posted in Mexico | Tagged COFEPRIS, GMP, GMP certificate, Good Manufacturing Practices, health authority, inspecitions, Latin America, Mexico, regulatory affairs | 6 Comments

ANMAT launches online platform to report drug adverse reactions

Posted on July 13, 2013 by Maria I. Guaia

On July 10th, 2013, ANMAT implemented a system for electronic submission of reports on adverse reactions to drug products. The system consists on an online form accessible from the website of the National System of Pharmacovigilance. You can access the online … Continue reading →

Posted in Argentina, Uncategorized | Tagged ANMAT, Argentina, drug adverse reactions, electronic submission, Latin America, pharmacovigilance, regulatory affairs | Leave a comment

Labeling update Argentina: gluten-free/gluten-containing compulsory claim

Posted on July 5, 2013 by Maria I. Guaia

Last month, after active lobbying by the Argentinian Association of Assistance to Celiacs, (ACELA) ANMAT decided to incorporate in the labeling texts of all drug products, information about their content of gluten. Celiac disease is a condition that damages the … Continue reading →

Posted in Uncategorized | Tagged ANMAT, Argentina, celiac disease, labeling, Latin America, regulatory affairs | Leave a comment